21 CFR § 520.1199 - Ivermectin, pyrantel, and praziquantel tablets.

---
identifier: "/us/cfr/t21/s520.1199"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 520.1199 - Ivermectin, pyrantel, and praziquantel tablets."
title_number: 21
title_name: "Food and Drugs"
section_number: "520.1199"
section_name: "Ivermectin, pyrantel, and praziquantel tablets."
chapter_name: "FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES"
subchapter_number: "E"
subchapter_name: "ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS"
part_number: "520"
part_name: "ORAL DOSAGE FORM NEW ANIMAL DRUGS"
positive_law: false
currency: "2026-04-05"
last_updated: "2026-04-05"
format_version: "1.1.0"
generator: "[email protected]"
authority: "21 U.S.C. 360b."
regulatory_source: "40 FR 13838, Mar. 27, 1975, unless otherwise noted."
cfr_part: "520"
---


# 520.1199 Ivermectin, pyrantel, and praziquantel tablets.

(a) *Specifications.* Each chewable tablet or soft chewable tablet contains:

(1) 34 micrograms (mcg) ivermectin, 28.5 milligrams (mg) pyrantel pamoate, and 28.5 mg praziquantel;

(2) 68 mcg ivermectin, 57 mg pyrantel pamoate, and 57 mg praziquantel;

(3) 136 mcg ivermectin, 114 mg pyrantel pamoate, and 114 mg praziquantel; or

(4) 272 mcg ivermectin, 228 mg pyrantel pamoate, and 228 mg praziquantel.

(b) *Sponsor.* See No. 051311 in § 510.600(c) of this chapter.

(c) *Conditions of use in dogs*—(1) *Amount.* Administer monthly according to body weight as follows:

(i) 6 to 12 lb: one tablet as described in paragraph (a)(1) of this section.

(ii) 12.1 to 25 lb: one tablet as described in paragraph (a)(2) of this section.

(iii) 25.1 to 50 lb: one tablet as described in paragraph (a)(3) of this section.

(iv) 50.1 to 100 lb: one tablet as described in paragraph (a)(4) of this section.

(v) Greater than 100 lb: use the appropriate combination of tablets.

(2) *Indications for use.* To prevent canine heartworm disease by eliminating the tissue stage of heartworm larvae (*Dirofilaria immitis*) for 1 month (30 days) after infection and for the treatment and control of roundworm (*Toxocara canis, Toxascaris leonina*), hookworm (*Ancylostoma caninum, Uncinaria stenocephala, Ancylostoma braziliense*) and tapeworm (*Dipylidium caninum, Taenia pisiformis*) infections.

(3) *Limitations.* Federal law restricts this drug to use by or on the order of a licensed veterinarian.

[71 FR 65052, Nov. 7, 2006, as amended at 78 FR 28822, May 20, 2014; 83 FR 14587, Apr. 5, 2018]